Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment after non-final office action filed August 10, 2026 is acknowledged. Claims 2-7, 11, 13, 15, 17-19, 24, 27 were cancelled, claim 1 was amended and claims 1, 8-10, 12, 14, 16, 20-23, 25-26, 28 are pending.
Election/Restrictions
The restriction requirement was deemed proper and made FINAL previously. Claims 8-10, 12, 14, 16, 20-23, 25-26 and 28 remain withdrawn from consideration as being drawn to a non-elected invention/species. Claim 1 is examined on the merits of this office action.
Withdrawn Objections/Rejections
The rejection of claim 1 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed August 10, 2026.
The rejection of claims 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US Patent No. 11771739 in view of Hawiger, Allergy and Asthma Network and Homey (see below reference citations) is withdrawn in view of filing and approval of a terminal disclaimer on August 10, 2026.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 11-19, 21, 23 of copending Application No. 18/479600 (reference application) in view of Hawiger,Allergy and Asthma Network and Homey (see below reference citations) is withdrawn in view of abandonment of the claims filed August 10, 2026.
Terminal Disclaimer
The terminal disclaimer filed on August 10, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11771739 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Maintained Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 remains provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of co-pending Application No. 18/939615 (reference application) in view of Hawiger (US2004235746 cited in Applicant’s IDS) Allergy and Asthma Network and Homey (see below reference citations). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims: A method of treating/inhibiting/reducing atopic dermatitis being mediated by TNFa, IL-1, IL-6, IL-10, Il-17 or MCP-1 the method comprising administering to the subject a therapeutically effective amount of a composition comprising a Nuclear Transport Modifier (NTM); wherein the NTM comprises the sequence set forth in SEQ ID NO: 2, SEQ ID SEQ ID NO: 5; SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, and/or SEQ ID NO: 16” (see claim 1).
Co-pending Application No. 18/939615 “A method of treating/inhibiting/reducing an inflammatory skin disease or inflammatory skin disorder caused by microbial, allergic, autoimmune, constitutive, metabolic, neoplastic and/or physical insults in a subject comprising…a therapeutically effective amount of a composition comprising a Nuclear Transport Checkpoint Inhibitor (NTCI)” (claim 1). Copending Application No. 18/939615 further claims “wherein the NTCI comprises the sequence set forth in SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3; SEQ ID NO: 4; SEQ ID NO: 5; SEQ ID NO: 6, SEQ ID NO: 7, SEQ ID NO: 8, SEQ ID NO: 9, SEQ ID NO: 13, SEQ ID NO: 16, SEQ ID NO: 17, SEQ ID NO: 18, SEQ ID NO: 19; SEQ ID NO: 20; SEQ ID NO: 21; SEQ ID NO: 22, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, SEQ ID NO: 27, SEQ ID NO: 28, SEQ ID NO: 29; SEQ ID NO: 30; SEQ ID NO: 31; SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 34, SEQ ID NO: 35, SEQ ID NO: 36, SEQ ID NO: 37, SEQ ID NO: 38, SEQ ID NO: 39; SEQ ID NO: 40; and/or SEQ ID NO: 41” (which are identical to the instant claims, see claim 2). Copending Application No. 18/939615 claims treating skin infections (claim 3); wherein the inflammatory skin disorder is caused by physical injury selected from the group consisting of abrasion, puncture, laceration, contusion, blunt force trauma, ischemia, surgery, bedsores, electric burn, sunburn, chemical burn, high temperature burn, low temperature burn, radiation injury, and skin aging (Claim 9); Skin Atrophy, Skin Aging, Xanthelasma, metabolic syndrome, diabetes mellitus, obesity, Gaucher’s disease, Phenylketonuria (PKU), Maple syrup urine disease (MSUD), fatty liver, hypercholesterolemia, hypertriglyceridemia, hyperthyroidism, hypothyroidism, dyslipidemia, hypolipidemia, seborrheic dermatitis, and galactosemia (claim 8). Co-pending Application No. 18/939615 doesn’t specifically claim wherein the autoimmune condition is atopic dermatitis or eczema .
Hawiger teaches that “Such NF-κB NLS-based peptides (i.e. SN50 or cSN50) can be used to treat, prevent, or reduce the effects of inflammatory diseases and conditions of the skin involving autoimmune or allergic responses, for example, but not limited to, psoriasis, eczema, contact dermatitis” (See paragraph 0157).
The additional references (Allergy and Asthma Network) and Homey teaches that atopic dermatitis is a cytokine-mediated inflammatory skin disease and is the most common form of eczema (see below rejection).
The co-pending Application claims the identical peptides, targeting inflammatory conditions (autoimmune and autoinflammatory) and physical injury mediated by cytokines using the same mechanism of action (nuclear transport inhibition) and administered to same organ (skin). A person of ordinary skill the art would have had a reasonable expectation of success in applying the NTMs disclosed in the co-pending application to treat skin inflammation mediated by cytokines regardless of whether the underlying cause is microbial, autoimmune or autoinflammatory. Furthermore, it would have been obvious to treat atopic dermatitis and eczema with the NTMs of the co-pending application. One of ordinary skill in the art would have been motivated to do so given Hawiger teaches the NTM peptides can be used to treat psoriasis, eczema, contact dermatitis and these disorders are encompassed by the genus of autoimmune/autoinflammatory disease as claimed by Co-pending Application No. 18/939615.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicants respectfully assert that because U.S. Application No. 18/939,615 is the later filed application, the appropriate application for submission of a terminal disclaimer, making arguments regarding the obviousness of the pending claims as it relates to alleged double patenting, or amending distinguishing claims is in U.S. Application No. 18/939,615. Accordingly, in view of the present amendments and because the cited art is the later filed application, Applicants assert that the present rejection is not properly applied to the present case and respectfully request its withdrawal.
Applicants arguments have been fully considered but not found persuasive. As discussed above the claims remain rejected on other grounds and therefore are not otherwise allowable. Accordingly, the basis of certified applicant for withdrawal of the provisional obvious type double patenting rejection is not present and the rejection is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 remains rejected under 35 U.S.C. 103 as being unpatentable over Hawiger (US2004235746 cited in Applicant’s IDS) in view of Hawiger* (US20140309159 A1, cited previously) and Allergy and Asthma Network (published on line 2018) and Homey (J ALLERGY CLIN IMMUNOL. VOLUME 118, NUMBER 1.
Hawiger discloses a method of using cSN50 (which comprises instant SEQ ID NO:4 (no longer in the claim but structurally similar to other SEQ ID Nos in the claim, see SEQ ID NO:12) for treatment of an inflammatory response in a subject and an inflammatory skin condition (see claim 17) which is caused by the toxin or an allergen (see paragraph 0065 and also Example VII). Hawiger teaches that “Such NF-κB NLS-based peptides (i.e. SN50 or cSN50) can be used to treat, prevent, or reduce the effects of inflammatory diseases and conditions of the skin involving autoimmune or allergic responses, for example, but not limited to, psoriasis, eczema, contact dermatitis” (See paragraph 0157). Hawiger further teaches that the inflammatory conditions targeted by the NTMs involve upregulation of proinflammatory cytokines including TNFa, IL-1 and IL-16 (see paragraphs 0111, 0051) and that treatment suppresses expression of these cytokines by interfering with nuclear translocation of transcription factors such as NFKB and STAT1 (see claim 21, paragraph 0069). Regarding claim 1, Hawiger teaches treatment of inflammatory skin conditions including psoriasis, eczema and contact dermatitis (0067 and 0157).
Hawiger is silent as to certain specific NTM peptide sequence variants as recited in the instant claims and specifically atopic dermatitis.
However Hawiger* teaches a composition for inflammatory disease or disorder in a subject comprising a pharmaceutically acceptable carrier and at least one importin beta-selective nuclear transport modifier (NTM) (see claim 1) and treating said disease/disorder. Hawiger* teaches wherein the NTM has SEQ ID NO:2 which is identical to instant SEQ ID NO:16 and also SEQ ID NO:5 (cSN50.1,SEQ ID NO:5) which is identical to instant SEQ ID NO:2. Hawiger* teaches modification of cSN50 to improve solubility (see paragraph 0051). Hawiger* teaches that the disclosed NTM peptides are useful for treating inflammatory diseases and disorders mediated by cytokine activity and nuclear transport of transcription factors, including inflammatory skin diseases and autoimmune or autoinflammatory conditions (see paragraphs 0007, 0067-0069). Hawiger* teaches the NTM peptide (instant SEQ ID NO:2) suppressed mediators of inflammation (TNF-alpha, IL-6) which are dependent on importin alpha mediated nuclear transport of proinflammatory SRTFs (see figure 10).
Allergy and Asthma Network teaches “Atopic dermatitis is a chronic inflammatory skin condition. It is the most common type of eczema” (see “Atopic Dermatitis”).
Homey teaches Atopic dermatitis (AD) is a common pruritic and chronically relapsing inflammatory skin disease with a steadily increasing prevalence (see abstract). Homey teaches that atopic dermatitis is a cytokine-mediated inflammatory skin disease involving TNF and interleukin signaling pathways (see Figure 1).
It would have been obvious before the effective filing date of the claimed invention to use the specific NTM peptide sequence variants taught by Hawiger* in the inflammatory skin disease treatment (eczema, dermatitis) of Hawiger. One of ordinary skill in the art would have been motivated to do so since both references teach the same class of NF-kB nuclear transport inhibitory peptides, the same mechanism of action (inhibition of nuclear import of proinflammatory transcription factors), and the same target disease space (inflammatory and autoimmune skin disorders including eczema (a type of atopic dermatitis) and contact dermatitis. Given the shared mechanism of action, overlapping peptides and overlapping therapeutic targets, a person of ordinary skill in the art would have had a reasonable expectation of success in sing the specific NTM peptide variants disclosed in Hawiger* including SEQ IDNO:2 and SEQ ID NO:5 variants, in the treatment methods of Hawiger. One of ordinary skill in the art would have been further motivated to use the Variants of Hawiger* given Hawiger* teaches the modification improved solubility which would be beneficial for therapeutic use.
Furthermore, the claimed peptides are different from the Hawiger by at most a limited amino acid substitution associated with improved solubility (see paragraph 0051). Hawiger* expressly teaches closely related sequence variants and substitutions to improve solubility and usability of NTM peptides. Optimization of peptide solubility and related formulation properties to improve therapeutic use through amino acid substitution represents routine and predictable optimization of a result effective variable in peptide arts. Such modification would have been obvious choice for one of ordinary skill in the art Under KSR (see MPEP 2141 III), where the prior art teaches the use of a known compound or class of compounds to treat related conditions involving the same biological mechanism, applying known sequence variants of that compound in an analogous therapeutic setting is an obvious variation.
Regarding treatment of atopic dermatitis, It would have been obvious before the effective filing date of the claimed invention to use the specific NTM peptide sequence variants taught by Hawiger in view of Hawiger* for treatment of atopic dermatitis. Hawiger teaches NF-κB nuclear transport inhibitory peptides useful for treating inflammatory and autoimmune skin disorders including eczema and contact dermatitis, while Hawiger* further teaches specific NTM peptide species and sequence variants and confirms their anti-inflammatory activity and suitability for therapeutic use. Allergy and Asthma Network teaches that atopic dermatitis is a chronic inflammatory skin condition and the most common form of eczema and Homey teaches that it is mediated by in part by inflammatory cytokines. Because the references teach the same class of peptides, the same mechanism of action (inhibition of nuclear import of pro-inflammatory transcription factors), and overlapping inflammatory skin disease targets, one of ordinary skill in the art would have been motivated to apply the Hawiger in view of Hawiger* peptides to atopic dermatitis with a reasonable expectation of success.
Regarding claim 1, the claim further recites that atopic dermatitis is mediated by TNF-α, IL-1, IL-6, IL-10, IL-17, or MCP-1. Hawiger teaches that the disclosed nuclear transport modifier peptides inhibit nuclear import of NF-κB and related transcription factors and thereby suppress pro-inflammatory cytokines including TNF-α, IL-1, and IL-6. Because the claim is written in the alternative (“or”), teaching suppression of one or more of the recited cytokines satisfies this limitation. Additionally, Homey teaches that atopic dermatitis is a cytokine-mediated inflammatory skin disease involving TNF and interleukin signaling pathways (see Figure 1). Therefore, the combined references teach and suggest treatment of atopic dermatitis mediated by the recited cytokines using the claimed peptide class.
Response to Applicant’s Arguments
Applicant argues that the cited references alone or in combination failed to account for all limitations of claim 1. Applicants arguments have been fully considered but not found persuasive. Hawiger teaches NTM peptides for treating inflammatory skin conditions including eczema and contact dermatitis. Hawiger* teaches the specific NTM peptide sequences including a peptide identical to instant SEQ ID NO:2, and teaches that the peptide suppresses inflammatory mediators including TNF alpha and IL-6. Allergy and asthma network teaches that atopic dermatitis is a chronic inflammatory skin condition and a form of eczema, while Homey teaches that atopic dermatitis is a cytokine mediated inflammatory disease involving TNF and interleukin signaling. Thus, the references collectively teach or suggest the limitations of instant claim one and provide a reason to apply the NTM peptides of Hawiger* to the inflammatory skin treatment taught by Hawiger for atopic dermatitis with a reasonable expectation of success.
Applicant argues that the claim sequences provide surprising and unexpected success in treating atopic dermatitis relying on Liu et al. as exhibit A. Applicants arguments have been fully considered but not found persuasive. Although Liu demonstrates efficacy of cSN50.1 in an experimental model of atopic dermatitis, Hawiger* already teaches the identical peptide corresponding to instant SEQ ID NO:2 and teaches its anti-inflammatory activity including suppression of TNF alpha and IL-6, which are expressly recited in claim 1. Thus, the results in Liu are consistent with biological activity already taught by the prior art. Applicant has not sufficiently established that the reported results are unexpected relative to the closest prior art rather than confirmation of the known anti-inflammatory properties of the same peptide.
Applicant argues that Liu results constitute objective evidence sufficient to overcome the 103 rejection. Applicants arguments have been fully considered but not found persuasive. Objective evidence of unexpected results must be considered with the evidence as a whole but even unexpected results may be insufficient where the evidence supporting obviousness is particularly strong (see MPEP716.01(d)). “Although the record may establish evidence of secondary considerations which are indicia of nonobviousness, the record may also establish such a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757, 769, 9 USPQ2d 1417, 1427 (Fed. Cir. 1988), cert. denied, 493 U.S. 814 (1989); Richardson-Vicks, Inc., v. The Upjohn Co., 122 F.3d 1476, 1484, 44 USPQ2d 1181, 1187 (Fed. Cir. 1997) (showing of unexpected results and commercial success of claimed ibuprofen and pseudoephedrine combination in single tablet form, while supported by substantial evidence, held not to overcome strong prima facie case of obviousness). See In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984) for a detailed discussion of the proper roles of the examiner’s prima facie case and applicant’s rebuttal evidence in the final determination of obviousness” (MPEP716.01). Here, the prior art teaches the identical peptide its suppression of inflammatory mediators recited in the claim, the use of the NTM peptide class for inflammatory skin conditions including eczema, and the cytokine mediated inflammatory nature of atopic dermatitis. Accordingly, the evidence of obviousness remains strong when weighed against applicants evidence (see MPEP 2145). The evidence submitted by applicant does not establish an unexpected property arising from a previously unknown peptide. Rather the prior already teaches the identical peptide, it's anti-inflammatory activity, suppression of inflammatory mediators expressly encompassed by claim 1, and use of the relevant NTM class in inflammatory skin disease. In view of these teachings, the results reported by Liu are consistent with anti-inflammatory properties that the prior art would have led one of ordinary skill in the art to expect.
Applicant’s argue that none of the references teach treatment of atopic dermatitis mediated by the claimed cytokines. Applicants argument has been fully considered but not found persuasive. Claim one recites the cytokines alternatively through and/or. Hawiger/Hawiger* teach suppression of at least TNF alpha and IL-6 while Homie teaches the involvement of TNF and interleukin signaling in atopic dermatitis. Accordingly the prior need not to establish mediation by every listed cytokine to satisfy the alternatively recited limitation. For all of the reasons set forth above, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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